PILOT STUDY OF CONCURRENT CHEMO ......PILOT STUDY OF CONCURRENT CHEMO-RADIOTHERAPY FOR ADVANCED...

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PILOT STUDY OF CONCURRENT CHEMO-RADIOTHERAPY FOR ADVANCED NASOPHARYNGEAL CARCINOMA (Forum for Nuclear Cooperation in Asia) Dr. Miriam Joy C. Calaguas Dept. of Radiation Oncology St. Luke’s Medical Center Quezon City, Philippines

Transcript of PILOT STUDY OF CONCURRENT CHEMO ......PILOT STUDY OF CONCURRENT CHEMO-RADIOTHERAPY FOR ADVANCED...

Page 1: PILOT STUDY OF CONCURRENT CHEMO ......PILOT STUDY OF CONCURRENT CHEMO-RADIOTHERAPY FOR ADVANCED NASOPHARYNGEAL CARCINOMA (Forum for Nuclear Cooperation in Asia) Dr. Miriam Joy C. Calaguas

PILOT STUDY OF CONCURRENT CHEMO-RADIOTHERAPY FOR

ADVANCED NASOPHARYNGEAL CARCINOMA

(Forum for Nuclear Cooperation in Asia)

Dr. Miriam Joy C. CalaguasDept. of Radiation Oncology

St. Luke’s Medical CenterQuezon City, Philippines

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LEAD AGENCY:

FORUM FOR NUCLEAR COOPERATION IN ASIA

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PROJECT BRIEF DESCRIPTION

• Non-randomized phase I-II trial.• Concurrent chemo-radiotherapy

standard radiotherapyweekly chemotherapy.

• chemotherapy may act or give synergistic effect w/ RT by sensitizing tumor cells.

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OBJECTIVES:• GENERAL:

Evaluate the acute & late toxicity of patients w/ NPC treated w/ standard RT concurrent w/ weekly chemotherapy.

• SPECIFIC:Determine the efficacy of the treatment

regimen as to response rate, duration of response & time-to-tumor progression or recurrence.

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SIGNIFICANCE OF THE STUDY:• 6th most common cancer among

Filipinos.• With improved RT techniques, local

control has also improved.• With chemotherapy, 3 year survival

has improved from 46% to 76%.• Incidence of distant failure reduced

from 35% to 13%.

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BRIEF LITERATURE REVIEW:• NPC is both radio & chemo sensitive.•• RADIOTHERAPY:RADIOTHERAPY:

- used as single modality for cure.

- highly curable in early stage.- poor outcome in advance

stages.- good local control.

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BRIEF LITERATURE REVIEW:

CHEMOTHERAPY:CHEMOTHERAPY:- undefined role.- taken as experimental.- adjuvant & neo adjuvant chemo

is not conclusive to benefit the patient.

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BRIEF LITERATURE REVIEW:

COMBINED CHEMORADIOTHERAPY:- concurrent chemoradiotherapy

improves survival in advance NPC.

- too toxic if given in large amount.- some chemotherapeutic regimen

are too toxic & has unacceptable morbidity.

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BRIEF LITERATURE REVIEW:

• Improved survival in cervical cancer is an attractive proposition in NPC.

• Weekly chemotherapy potentially cause continued enhancement of RT effect to tumor cells.

• Easier to increase or adjust in presence of acute complications.

• This regimen is a common practice in cervix cancer management.

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BRIEF LITERATURE REVIEW:

Why concurrent chemoradiotherapy?- acts synergistically with

radiation by sensitizing cell to RT.- chemotherapy synchronizes

cells into a more radiation sensitive phase and potentiate the effect of RT.

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RESEARCH METHODOLOGY

• Non-randomized phase I/II trial in Asia and Southeast Asian multi-center study:

• Participating countries:Vietnam (2 centers) Malaysia(2 centers)

Indonesia ChinaPhilippines ThailandKorea Japan

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RESEARCH METHODOLOGY

Conduct of study:This study will be conducted

according to Good Clinical Practice guidelines and Declaration of Helsinki.

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RESEARCH METHODOLOGY• Evaluation before treatment:• Medical history & PE• ENT evaluation• Biopsy/histopathology report• CXR, CT scan of post-nasal space up to

thoracic inlet. (MRI & bone scan optional.)

• Nutritional & dental assessment• Blood chemistries

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RESEARCH METHODOLOGY• Treatment protocol:

Concurrent chemoradiotherapy• RT: Standard fractionation (1.8 to 2

Gy/day for 6.5 to 7.5 weeks).• Chemotherapy: weekly cisplatinum

at 30 mg/m2, IV infusion.

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RESEARCH METHODOLOGY• Prophylactic medications:• Radiotherapy = dental clearance & oral

fluoride prophylaxis.• Chemotherapy = dexamethasone

p.o. given 2 days prior to start of chemo, routine hydration and anti-emetics.

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RESEARCH METHODOLOGYTarget population:

ONLY THREE PATIENTS IN THE PHILIPPINES

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RESEARCH METHODOLOGY

INCLUSION CRITERIA:Age range (20 - 70 y.o.)Biopsy proven WHO type 2 or 3, NPCStage III, IVA & IVB (TNM 1997)No distant metastasesNo previous history of cancer except

stage 0 carcinoma of cervix or basal cell carcinoma.

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RESEARCH METHODOLOGY

INCLUSION CRITERIA:WHO performance status 0-2WBC > 3,500/LPlatelet count > 100,000/LHemoglobin > 10 gm/dLCrea clearance > 6ml/minPatients should be accessible to

follow-up.

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RESEARCH METHODOLOGY

EXCLUSION CRITERIA:WHO type I NPCStage IV CWHO performance status > 3History of cancer within 5 years

except for skin cancer & CIS of cervix.

Previous RT to head and neck.

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RESEARCH METHODOLOGYEXCLUSION CRITERIA:

– severe concomitant medical illness like uncontrolled diabetes or hypertension.

– Concurrent chemotherapy or investigational therapy.

– pregnancy and/or lactation– patients who are unlikely to follow-

up.

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PATIENT ASSESSMENT

During treatment:- weekly assessment for toxicity.- toxicity grading according to

standard NCICTC/WHO criteria.- toxicity evaluation shall include the

skin, mucosa, nausea, vomiting and weight loss.

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Stopping rule:

WBC < 3,000/mm3

Platelet count <75,000/mm3

Fever > 38 0 CPerformance status: 3-4Grade 3 nausea

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Stopping rule:

When patients develop grade 3-4 non-hematological toxicities (mucositis), chemotherapy or radiotherapy should be interrupted according to institutional policy.

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CRITERIA FOR DISCONTINUATION OF TREATMENT

• Progressive disease (PD)• Very serious acute toxicities:

- grade 4 non-hematological toxicities.- septic shock due to hematologic

toxicities.- treatment related death.

• denial or withdrawal of the protocol treatment.

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CRITERIA FOR DISCONTINUATION OF TREATMENT

• Interruption of radiotherapy more than 3 weeks.

• Cases that are judged to be difficult to continue the protocol treatment by the responsible physician.

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PATIENTS’ PROFILE

• 3 patients enrolled in the study.• Age ranged from 46 – 62 years old.• All are males.• Filipino

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CASE 1:

• I. C. , 46 years old.• Chief complaint - blurring of vision.

- bilateral rectus musclepalsy.

• Biopsy of the nasopharyngeal mass:- poorly differentiated squamous cell

CA.

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CASE 1:

• CT scan of the nasopharynx:- soft tissue fullness in the left side of

nasopharynx with blunting of the torus tobarius.

- Fossa of Rossenmuller obliterated.• CT scan of the brain and orbit:

- negative

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CASE 1:

• Metastatic work-up : all are negative.• Clinical and radiologic diagnosis/

staging:poorly differentiated NPCA stage

1VA ( T4N1Mx ).

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CASE 2:R. F. , 62 years old.

Chief complaint - bilateral neck mass.

Biopsy of the right supraclavicular mass:

large cell undifferentiated CA

LCA ( - ), Cytokeratin (+)

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CASE 2:

CT Scan of the nasopharynx / neck:- soft tissue fullness on the right side of

nasopharynx extending to the oropharynx with attenuation of ipsilateral parapharyn-geal space.

-enlarged lypmh nodes both internal jugular, supraclavicular, posterior cervical,

submandibular.

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CASE 2:

• Metastatic work-up : negative• Clinical and radiologic staging:

undifferentiated NPCA stage 1VB( T2bN3bMx )

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CASE 3:

• H.R., 56 year old male• Chief complaint - bilateral neck mass

- bilateral rectus muscle palsy

• Biopsy of the neck mass:- Undifferentiated CA- Cytokeratin( -), LCA ( + )

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CASE 3CT Scan of the Nasopharynx/ Neck/ Head

- Soft tissue fullness obliterating the NP extending to posterior nasal cavity , sphenoid, ethmoid, clivus, prepontinecisterns.

- Enlarged lymph nodes in the internal jugular

chain, posterior cervical spaces.

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CASE 3:

• Metastatic work-up: negative• Clinical and radiologic diagnosis:

undifferentiated NPCA stage 1VB ( T4N3bMx ).

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RESULTS:

All of the 3 patients completed the prescribe dose of chemoradiotxEXCEPT for the 3rd patient with interruption on the 6th week for 1week because of grade 3 mucositis.

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TOXICITY INTRA-CHEMORT

PATIENT 1

WEEK 1

WEEK 2

WEEK 3

WEEK 4

WEEK 5

WEEK 6

WEEK 7

WEEK 8

SKIN 0 0 2 2 2 2 3 3

MUCOSITIS 0 0 1 2 2 2 2 2

NAUSEA 0 0 0 0 0 0 0 0

VOMITING 0 0 0 0 0 0 0 0

WEIGHT LOSS 0 0 0 0 0 0 0 0

HEMATOLOGC 0 0 0 0 0 0 0 0

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TOXICITY INTRA-CHEMORTPATIENT 2

WEEK 1

WEEK 2

WEEK 3

WEEK 4

WEEK 5

WEEK 6

WEEK 7

WEEK 8

SKIN 0 1 2

3

3

3

3 3

MUCOSITIS 0 0 2 2 2 2 2 2

NAUSEA 0 0 0 0 0 0 0 0

VOMITING 0 0 0 0 0 0 0 0

WEIGHT LOSS 0 0 0 0 0 0 0 0

HEMATOLOGIC 0 0 0 0 0 0 0 0

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TOXICITY INTRA CHEMORTPATIENT 3

WEEK 1

WEEK 2

WEEK 3

WEEK 4

WEEK 5

WEEK 6

WEEK 7

WEEK 8

SKIN 0 0 1 2 2 3 2 2

MUCOSITIS 0 1 2 2 2 3 2 3

NAUSEA 0 0 0 0 0 1 0 1

VOMITING 0 0 0 0 0 1 0 1

WEIGHT LOSS 0 0 0 0 0 0 0 0

HEMATOLOGIC 0 0 0 0 0 0 0 0

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FOLLOW-UP:

CT Scan due for: Case 1 - Dec. 2003 Case 2- Jan. 2004Case 3 - Mar. 2004

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MARAMING SALAMAT PO!MARAMING SALAMAT PO!

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